Epilepsy patient Valerie Corral, co-founder of the Wo/Men's Alliance for Medical Marijuana, has joined the lawsuit. Senators Kerry and Edwards both support the research project by UMass / Amherst Professor Lyle Craker.

[Marijuana Policy Project] WASHINGTON - July 20 - In a pair of federal lawsuits to be filed on Wednesday, July 21, researchers charge the U.S. Drug Enforcement Administration, U.S. Department of Health and Human Services, National Institutes of Health, and National Institute on Drug Abuse with obstructing medical marijuana research in violation of federal law. They are joined in the legal action by patient Valerie Corral, co-founder of the Wo/Men's Alliance for Medical Marijuana (WAMM) in Santa Cruz, California, who uses marijuana to control epileptic seizures.

The legal complaints can be downloaded at http://www.maps.org/mmj/dealawsuit.pdf and http://www.maps.org/mmj/hhs-nih-nidalawsuit/pdf .

On June 25, 2001, Lyle Craker, Ph.D., director of the Medicinal Plant Program at the University of Massachusetts Amherst, filed an application with the DEA for approval to establish a facility that would produce marijuana for U.S. Food and Drug Administration-approved research. Currently, all marijuana for research in the U.S. must come from a crop grown on a NIDA-contracted farm in Mississippi. NIDA's product has been only inconsistently available to researchers and is infamous for its low quality.

Three years later, the DEA has yet to act on the UMass application, even though it has the backing of U.S. Senators John Kerry and Edward Kennedy, who sent a letter of support to the DEA in October 20, 2003. Craker and the Multidisciplinary Association for Psychedelic Studies (MAPS), which would fund the UMass facility, charge that the DEA's refusal to act on the proposal has caused an unreasonable delay in violation of the federal Administrative Procedures Act, making it impossible for MAPS to conduct studies that could lead to FDA's approval of marijuana as a prescription drug.

"There is an urgent need for an alternative supply of marijuana for medical research," Craker said. "Independent sources are allowed to produce other Schedule I drugs -- including MDMA (ecstasy) -- for research, but NIDA maintains a monopoly on research marijuana. Many researchers believe that NIDA's monopoly is an obstacle to getting needed studies done on a timely basis." The suit filed by Craker. MAPS, and Valerie Corral against the DEA notes that NIDA has refused to supply marijuana for at least two FDA-approved research protocols submitted by respected scientists, one for treatment of AIDS wasting syndrome and another for treatment of migraine headaches.

"We first filed our application with the DEA on June 25, 2001," Craker explained. "After three years of waiting and repeated delays, we still don't have an answer."

"Because NIDA's marijuana is only available for research and not for prescription use, no pharmaceutical company would ever use it for research aimed at the licensing of marijuana as a prescription drug," explained MAPS President Rick Doblin, Ph.D. "The FDA would need to review research conducted with the product that would actually be sold, and there is no prospect of that happening with NIDA's marijuana. The process of seeking FDA approval of marijuana cannot begin until an alternative source of research marijuana is available."

The DEA is also charged in the suit with blocking a MAPS-sponsored study of vaporizer technology, which has the potential to reduce or eliminate smoking-related hazards associated with medical use of marijuana. The proposed study uses no human subjects and thus carries no possible risk of harm; it simply involves analyzing the vapor stream produced by the device for the presence of active marijuana components, called cannabinoids, and for the unwanted contaminants that occur in smoke.

MAPS has sought to obtain 10 grams of marijuana for this study from the Dutch Office of Medicinal Cannabis, the Dutch government agency that supplies medical marijuana to pharmacies in the Netherlands. Such an action requires DEA approval, but this application, filed June 24, 2003, also remains in bureaucratic limbo, with the research unable to proceed. MAPS has also attempted to purchase 10 grams of NIDA marijuana for the vaporizer study, and that application -- also filed June 24, 2003 -- remains stalled as well, resulting in a separate suit filed by MAPS and Corral against HHS, NIH, and NIDA.

"We should welcome, rather than feel threatened by, scientific research into the medical uses of marijuana," says Dr. Barbara Roberts, former senior policy analyst and acting deputy director for demand reduction in the Office of National Drug Control Policy, who left in September 2003 after serving for 10 years. "DEA licensing of the UMass Amherst facility, importation, and timely reviews by HHS of protocols are solutions, not problems."

"This litigation is necessary because of the federal government's obstructionism regarding medical marijuana research," said Steve Fox, director of government relations for the Marijuana Policy Project in Washington, D.C. "The government regularly claims that if marijuana were really medicine, it would already have been approved by the FDA, and that more research is needed, yet they have not only failed to support medical research, they've actively obstructed it."

"As a patient, each day brings new struggles," said Valerie Corral, founder of the WAMM medical marijuana collective raided by the DEA in 2002. "Instead of providing relief for critically ill Americans, our government refuses to allow the research that would free sick and dying members of our collective from living in fear of an administration that views medical assistance as criminal activity."

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COMMENT: we have found legitimate uses for opiods and amphetamines in medicine, and they are approved for use by prescription. It's about time we seriously consider a nationwide recognition of the medical uses of inhaled cannabinoids.

http://www.commondreams.org/cgi-bin...004/0720-10.htm